Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators

Test, Epithelial Ovarian Tumor Associated Antigen (he4)

Fujirebio Diagnostics, Inc.

The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G He4 Immunoreaction Cartridges, Lumipulse G He4 Calibrators.

Pre-market Notification Details

Device IDK151378
510k NumberK151378
Device Name:Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
ClassificationTest, Epithelial Ovarian Tumor Associated Antigen (he4)
Applicant Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern,  PA  19355
ContactDiana Dickson
CorrespondentStacey Dolan
Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern,  PA  19355
Product CodeOIU  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-22
Decision Date2015-11-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987270234181 K151378 000
04987270234174 K151378 000

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